Practicing Alternative Techniques to Heal From Depression: The PATH-D Study
This study is currently recruiting participants.
Verified June 2012 by University of California, San Francisco
Sponsor:
University of California, San Francisco
Collaborator:
Information provided by (Responsible Party):
Stuart Eisendrath, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01021254
First received: November 24, 2009
Last updated: June 12, 2012
Last verified: June 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 24, 2009 | ||||||||
| Last Updated Date | June 12, 2012 | ||||||||
| Start Date ICMJE | September 2009 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Baseline, 4,8,24,36,52 week ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01021254 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Practicing Alternative Techniques to Heal From Depression: The PATH-D Study | ||||||||
| Official Title ICMJE | Applying Mindfulness-Based Cognitive Therapy to Treatment-Resistant Depression | ||||||||
| Brief Summary | This study is a randomized, controlled trial of Mindfulness-Based Cognitive Therapy (MBCT) versus the Health-Enhancement Program (HEP) for patients with treatment-resistant depression. Both arms of the study will continue to receive the standard medication management treatment as usual (TAU) throughout the study. |
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| Detailed Description | Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week group intervention that uses mindfulness meditation as its core therapeutic ingredient. It teaches people to have a different relationship to depressive thoughts and feelings. The Health-Enhancement Program (HEP) was developed by researches at the University of Wisconsin, Madison. It has been shown to decrease global stress levels and to increase perceived health which literature has indicated to be contributors to depression. 124 patients with major depressive disorder (MDD)and who have failed to remit from two or more adequate antidepressant trials will be identified and randomized to one of two treatment arms: MBCT+TAU or HEP +TAU. All patients enrolled in the study will undergo research assessments pre and post treatment (baseline and 8-week) and follow-up assessments at months 3,6,9, and 12. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | |||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Major Depressive Disorder | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 124 | ||||||||
| Estimated Completion Date | February 2013 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01021254 | ||||||||
| Other Study ID Numbers ICMJE | RO1 AT004572-O1A1 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Stuart Eisendrath, University of California, San Francisco | ||||||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||||||
| Collaborators ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||||||
| Verification Date | June 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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